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Enhancing Equitable and Effective (E-3) Post Traumatic Stress Disorder (PTSD) Disability Assessment (E-3PTSD)

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CAPS/WHODAS
Nonstructured Interview
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Post-Traumatic Stress Disorder focused on measuring Disability Examination, Clinician Administered PTSD Scale, Quality of Care

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Veterans referred to VHA for an Initial PTSD Compensation and Pension Examination
  2. Informed consent

Exclusion Criteria:

  1. Mentally impaired, not able to give informed consent
  2. English speaking

Sites / Locations

  • Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
  • VA Palo Alto Health Care System, Palo Alto, CA
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  • Southeast Louisiana Veterans Health Care System, New Orleans, LA
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  • John D. Dingell VA Medical Center, Detroit, MI
  • Minneapolis VA Health Care System, Minneapolis, MN
  • New Mexico VA Health Care System, Albuquerque, NM
  • Memphis VA Medical Center, Memphis, TN
  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
  • Clement J. Zablocki VA Medical Center, Milwaukee, WI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CAPS/WHODAS

Nonstructured Interview

Arm Description

PTSD assessed using Clinical Assessment of PTSD Symptoms (CAPS) and WHODAS functional impairment structured evidence-based interview

Usual clinical interview to assess PTSD, without CAPS or WHODAS

Outcomes

Primary Outcome Measures

Completeness and Quality of PTSD Interview
total completeness of diagnostic assessment score, range from 0 to 100% and completeness of functional assessment

Secondary Outcome Measures

PTSD Diagnosis
Number of participants who were unable to receive a conclusive clinician PTSD diagnosis for positive or negative PTSD symptoms (unable to determine clinician diagnosis).
Patient Satisfaction
Mean score on satisfaction survey rating scale from 1 to 5 (higher)
Resource Utilization
time spent administering the exam

Full Information

First Posted
June 12, 2008
Last Updated
July 19, 2018
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00699660
Brief Title
Enhancing Equitable and Effective (E-3) Post Traumatic Stress Disorder (PTSD) Disability Assessment
Acronym
E-3PTSD
Official Title
Enhancing Equitable and Effective PTSD Disability Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project evaluated the impact of semi-structured, standardized interviews on the initial PTSD C&P on the examination.
Detailed Description
Our objective is to compare the process and outcomes of C&P exams for PTSD conducted with CAPS and WHODAS-II interviews versus the PTSD exams conducted without the CAPS and WHODAS-II interviews. This project will conduct a randomized controlled trial on 688 veterans to evaluate the effects of the CAPS/WHODAS instruments on the initial PTSD C&P examination process. Study outcomes include variation in assessing the DSM-IV components of PTSD, diagnostic accuracy, veteran perception of the exam process, VBA rater utility and resource utilization. This project will 1) demonstrate the feasibility of conducting program evaluation and intervention studies on the PTSD C&P examination process, 2) develop research tools, instruments and methods for C&P evaluation, 3) provide data on the value-added contribution of CAPS and WHODAS-II to the PTSD assessment process and examination report, and 4) inform the business case of utilizing the CAPS and WHODAS-II in the PTSD C&P process. The ultimate aim is to improve the reproducibility, consistency and validity of the PTSD examination process while maintaining a level of efficiency and cost restraint that provides veterans with an exam process that is fair, accurate and equitable across VHA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
Disability Examination, Clinician Administered PTSD Scale, Quality of Care

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAPS/WHODAS
Arm Type
Experimental
Arm Description
PTSD assessed using Clinical Assessment of PTSD Symptoms (CAPS) and WHODAS functional impairment structured evidence-based interview
Arm Title
Nonstructured Interview
Arm Type
Active Comparator
Arm Description
Usual clinical interview to assess PTSD, without CAPS or WHODAS
Intervention Type
Behavioral
Intervention Name(s)
CAPS/WHODAS
Intervention Description
CAPS/WHODAS structured clinical PTSD interview
Intervention Type
Behavioral
Intervention Name(s)
Nonstructured Interview
Other Intervention Name(s)
Usual Clinical Interview
Intervention Description
Usual PTSD clinical PTSD interview, not CAPS or SCID
Primary Outcome Measure Information:
Title
Completeness and Quality of PTSD Interview
Description
total completeness of diagnostic assessment score, range from 0 to 100% and completeness of functional assessment
Time Frame
Post-exam, same day
Secondary Outcome Measure Information:
Title
PTSD Diagnosis
Description
Number of participants who were unable to receive a conclusive clinician PTSD diagnosis for positive or negative PTSD symptoms (unable to determine clinician diagnosis).
Time Frame
Post-exam, same day
Title
Patient Satisfaction
Description
Mean score on satisfaction survey rating scale from 1 to 5 (higher)
Time Frame
post-exam, same day
Title
Resource Utilization
Description
time spent administering the exam
Time Frame
same day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans referred to VHA for an Initial PTSD Compensation and Pension Examination Informed consent Exclusion Criteria: Mentally impaired, not able to give informed consent English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore Speroff, PhD
Organizational Affiliation
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72114-1706
Country
United States
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Southeast Louisiana Veterans Health Care System, New Orleans, LA
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
John D. Dingell VA Medical Center, Detroit, MI
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
New Mexico VA Health Care System, Albuquerque, NM
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108-5153
Country
United States
Facility Name
Memphis VA Medical Center, Memphis, TN
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2637
Country
United States
Facility Name
Clement J. Zablocki VA Medical Center, Milwaukee, WI
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295-1000
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23821175
Citation
Rosen MI, Afshartous D, Marx BP. Did microinsults and microaggressions play a role?: in reply. Psychiatr Serv. 2013 Jul 1;64(7):713. doi: 10.1176/appi.ps.640703. No abstract available.
Results Reference
result
PubMed Identifier
23318842
Citation
Rosen MI, Afshartous DR, Nwosu S, Scott MC, Jackson JC, Marx BP, Murdoch M, Sinnott PL, Speroff T. Racial differences in veterans' satisfaction with examination of disability from posttraumatic stress disorder. Psychiatr Serv. 2013 Apr 1;64(4):354-9. doi: 10.1176/appi.ps.201100526.
Results Reference
result
PubMed Identifier
23225029
Citation
Speroff T, Sinnott PL, Marx B, Owen RR, Jackson JC, Greevy R, Sayer N, Murdoch M, Shane AC, Smith J, Alvarez J, Nwosu SK, Keane T, Weathers F, Schnurr PP, Friedman MJ. Impact of evidence-based standardized assessment on the disability clinical interview for diagnosis of service-connected PTSD: a cluster-randomized trial. J Trauma Stress. 2012 Dec;25(6):607-15. doi: 10.1002/jts.21759.
Results Reference
result
Citation
Marx BP, Jackson JC, Schnuff PP, Murdoch M, Sayer NA, Keane TM, Friedman MJ, Greevy RA, Owen RR, Sinnott PL, Speroff T. The reality of malingered PTSD among Veterans: Reply to McNally and Frueh. Journal of traumatic stress. 2012 Aug 1; 25(4):457-60.
Results Reference
result
PubMed Identifier
21913226
Citation
Jackson JC, Sinnott PL, Marx BP, Murdoch M, Sayer NA, Alvarez JM, Greevy RA, Schnurr PP, Friedman MJ, Shane AC, Owen RR, Keane TM, Speroff T. Variation in practices and attitudes of clinicians assessing PTSD-related disability among veterans. J Trauma Stress. 2011 Oct;24(5):609-13. doi: 10.1002/jts.20688. Epub 2011 Sep 12.
Results Reference
result
PubMed Identifier
18410194
Citation
Marx BP, Marshall PJ, Castro F. The moderating effects of stimulus valence and arousal on memory suppression. Emotion. 2008 Apr;8(2):199-207. doi: 10.1037/1528-3542.8.2.199.
Results Reference
result
PubMed Identifier
18410204
Citation
Sloan DM, Marx BP, Epstein EM, Dobbs JL. Expressive writing buffers against maladaptive rumination. Emotion. 2008 Apr;8(2):302-6. doi: 10.1037/1528-3542.8.2.302.
Results Reference
result

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Enhancing Equitable and Effective (E-3) Post Traumatic Stress Disorder (PTSD) Disability Assessment

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